NCT03917563Unknown不适用
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2019年4月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
研究概览
简要总结
The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years of age or above;
- •Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
- •Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.
排除标准
- •Patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- •Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
- •Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
研究组 & 干预措施
Intervention group
Experimental
WATCHMAN LAA occluder treatment
干预措施: WATCHMAN LAA occluder (Device)
结局指标
主要结局
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
时间窗: 12 months post procedure
次要结局
- Bleeding(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)
- Vascular access-related complications(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)
- Device-related complications(Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure)
研究者
研究点 (1)
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